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NCT Number: NCT07466342

Vitamin E Plus Mefenamic Acid Versus Mefenamic Acid Alone for Treating Primary Dysmenorrhea in Women

The goal of this clinical trial is to determine whether adding vitamin E to mefenamic acid reduces menstrual pain more effectively than mefenamic acid alone in women with primary dysmenorrhea. Primary dysmenorrhea refers to painful menstrual cramps that occur without an underlying pelvic disease.

The main question this study aims to answer is:

• Does the combination of vitamin E and mefenamic acid reduce menstrual pain more than mefenamic acid alone?

Researchers will compare two groups of women aged 15-35 years who experience primary dysmenorrhea. One group will receive mefenamic acid together with vitamin E, while the other group will receive mefenamic acid alone.

A total of 60 participants will be enrolled and randomly assigned to one of the two treatment groups. Participants in the combination group will take mefenamic acid 400 mg with vitamin E 400 IU at the start of their menstrual cycle. Participants in the comparison group will take mefenamic acid 400 mg alone at the start of their menstrual cycle.

Pain will be measured using a Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents severe pain. Pain scores will be recorded at the time of enrollment and again during the second menstrual cycle after starting treatment.

The study will evaluate whether the average pain score during the second menstrual cycle is lower in women who receive vitamin E together with mefenamic acid compared with those who receive mefenamic acid alone. The findings may help determine whether adding vitamin E can improve the management of primary dysmenorrhea.

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Key information

Age range

15 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nishtar Medical University and Hospital

Multan, Punjab Province, 60000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary Dysmenorrhea for ≥3-months

Exclusion criteria

  • Patients already taking Vitamin E therapy
  • Having secondary dysmenorrhea like fibroid, endometriosis, adenomyosis and ovarian cyst on ultrasound

Treatment and study plan

mefenamic acid

Drug

All participants will be given 250 mg of Mefenamic acid (Tablet Ponstan), twice daily, for 5 days: two days before the start of menstruation to three days in menstrual cycle

Other names: Ponstan

Vitamin E capsule

Drug

All participants will be given 200 mg of Vitamin E (Evion capsule), twice daily, for 5 days: two days before the start of menstruation to three days in menstrual cycle

Other names: Tocopheryl Acetate, Evion capsule

Primary outcomes

  1. Change in Pain Score

    Time frame: After enrollment, two days before menstruation to three days in menstrual cycle

    Pain will be assessed using Visual analogue Scale, for five days, two days before menstruation to three days in menstrual cycle.

    Mean Pain Score = (VAS Day 1 + Day 2 + Day 3 + Day 4 + Day 5) ÷ 5 Mean Pain Score in the Baseline Cycle (without treatment) and Cycle 2 (with study medication) will be recorded.

    Change in Pain=Mean VAS (Cycle 2)-Mean VAS (Baseline Cycle)

Sponsors and collaborators

Lead sponsor

Nishtar Medical University

Other

Registry information

Official study title

Comparison of Vitamin E in Combination With Mefenamic Acid Versus Mefenamic Acid Alone for Management of Primary Dysmenorrhea

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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